Department of Surgery, Leiden University Medical Centre, Leiden, The Netherlands.
Department of Surgery, Red Cross Hospital, Beverwijk, The Netherlands.
Wound Repair Regen. 2019 May;27(3):257-267. doi: 10.1111/wrr.12699. Epub 2019 Feb 11.
Although partial thickness burns are the most frequently reported burn injuries, there is no consensus on the optimal treatment. The objective of this study was to compare the clinical effectiveness and scar quality of Flaminal® Forte to silver sulfadiazine (Flamazine®) in the treatment of partial thickness burns. In this two-arm open label multicenter randomized controlled trial, adult patients with acute partial thickness burns and an affected total body surface area of less than 30% were randomized between Flaminal® Forte and Flamazine® and followed for 12 months. Dressing changes in the Flamazine® group were performed daily, and in the Flaminal® group during the first 3 days post burn and thereafter every other day until complete wound healing or surgery. Forty-one patients were randomly allocated to Flaminal® Forte and 48 patients to Flamazine®. The primary outcome was time to wound healing, which did not differ between the groups: median 18 days with Flaminal® Forte (range 8-49 days) versus 16 days with Flamazine® (range 7-48 days; p = 0.24). Regarding the secondary outcomes during hospital admission, there were no statistically significant differences between the groups concerning need for surgery, pain scores, pruritus, or pain-related and anticipatory anxiety. More patients in the Flaminal® group developed wound colonization (78% versus 32%, p < 0.001), but the treatment groups did not differ regarding the incidence of local infections and use of systemic antibiotics. In terms of scar quality, no statistically significant differences between both treatment groups were found regarding subjective scar assessment (Patient and Observer Scar Assessment Scale (POSAS)), scar melanin and pigmentation (DermaSpectrometer®), and scar elasticity and maximal extension (Cutometer®) during 12 month postburn. In conclusion, time to wound healing did not differ, but the use of Flaminal® Forte seemed favorable because less dressing changes are needed which lowers the burden of wound care.
尽管部分厚度烧伤是最常报告的烧伤损伤，但对于最佳治疗方法尚无共识。本研究的目的是比较 Flaminal® Forte 与磺胺嘧啶银（Flamazine®）治疗部分厚度烧伤的临床效果和疤痕质量。在这项双臂开放性标签多中心随机对照试验中，将急性部分厚度烧伤且受累总体表面积小于 30%的成年患者随机分为 Flaminal® Forte 组和 Flamazine® 组，并随访 12 个月。Flamazine® 组每天进行换药，Flaminal® 组在烧伤后前 3 天每天进行一次，之后每隔一天一次，直至完全愈合或手术。41 例患者被随机分配到 Flaminal® Forte 组，48 例患者被分配到 Flamazine® 组。主要结局是伤口愈合时间，两组之间没有差异：Flaminal® Forte 组中位数为 18 天（范围 8-49 天），Flamazine® 组中位数为 16 天（范围 7-48 天；p=0.24）。关于住院期间的次要结局，两组之间在手术需求、疼痛评分、瘙痒、疼痛相关和预期性焦虑方面没有统计学上的显著差异。Flaminal® 组更多的患者发生伤口定植（78%比 32%，p<0.001），但两组之间局部感染和全身使用抗生素的发生率没有差异。在疤痕质量方面，两组之间在主观疤痕评估（患者和观察者疤痕评估量表（POSAS））、疤痕黑色素和色素沉着（DermaSpectrometer®）以及疤痕弹性和最大伸展（Cutometer®）方面均无统计学差异。综上所述，伤口愈合时间没有差异，但 Flaminal® Forte 的使用似乎更为有利，因为需要的换药次数更少，从而降低了伤口护理的负担。
